Using Cardiac MRI to Characterise the Dynamic Changes Which Occur in the Acutely Reperfused STEMI Patient

NCT ID: NCT02791165

Last Updated: 2016-06-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-12-31

Study Completion Date

2017-01-31

Brief Summary

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There is an optimal day on which to perform the CMR scan which allows one to capture the information required to assess the dynamic changes in the reperfused STEMI patient. The main objective is to characterise the dynamic changes in LV function, MI size, myocardial edema, MVO, IMH, interstitial volume in the remote myocardium over the first 10 days of an acute reperfused STEMI in order to identify the optimal day for performing the CMR scan.

Detailed Description

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This will be a prospective observational study with serial CMR imaging only.

CMR scan Each patient will receive one CMR scan performed on Day 1, Day 3, Day 5, Day 10 following the PPCI procedure on a 3T Philips scanner (see study flow below). All CMR scans will be analysed at a central CMR corelab.

For Day 1, 3, 5, 7 and 10 CMRs, parameters will be collected as follows:

* Left ventricle (LV) ejection fraction and indexed LV end systolic and diastolic volumes and mass using short-axis SSFP cine imaging and myocardial tagging sequences).
* The AAR by T1 and T2 mapping18 as a percentage of the LV over time.
* Signal intensity of T1 and T2 mapping in the MI zone, MI core and remote myocardium over time.
* The incidence of intramyocardial haemorrhage (IMH)(hypo-enhancement on T2\* mapping sequence)26.
* The volume of microvascular obstruction (MVO) defined as signal intensity 2 standard deviated below the mean signal intensity of the remote myocardium on the T2\* maps.

Additional sequence for Day 3 and 7 CMR scans:

• All the above plus MI size (measured in mass of LGE and expressed as a percentage of the LV mass).

Conditions

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STEMI

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

1. Confirmed STEMI as per PPCI procedure reports/ clinical notes
2. Proximal to mid coronary artery occlusion.
3. Ability to provide informed consent

Exclusion Criteria

1. Previous myocardial infarction or coronary artery bypass graft surgery
2. Contraindication for CMR (e.g. ferromagnetic implants, claustrophobia, estimated glomerular filtration rate \<30mL/min)
Minimum Eligible Age

21 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Heart Centre Singapore

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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National Heart Centre Singapore

Role: PRINCIPAL_INVESTIGATOR

National Heart Centre Singapore

Locations

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National Heart Centre Singapore

Singapore, Singapore, Singapore

Site Status RECRUITING

Countries

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Singapore

Central Contacts

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Mung Peng

Role: CONTACT

6704 ext. 2267

Facility Contacts

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Mung Peng

Role: primary

6704 ext. 2267

Other Identifiers

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2015/3033

Identifier Type: -

Identifier Source: org_study_id

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